| CTRI Number |
CTRI/2024/04/065911 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Amrutadi Kwath and Kaishor Guggul in patients with Vatarakta with special reference to Hyperuricaemia.
|
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Scientific Title of Study
|
An Open Randomized Comparative clinical study of Amrutadi kwath (Sharangdhar samhita) with Kaishor guggul (Sharangdhar samhita) in the management of Vatarakta with special reference to Hyperuricemia.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Harish Agrawal |
| Designation |
PG scholar |
| Affiliation |
APMs, Ayurveda Mahavidyalay sion, Mumbai |
| Address |
Karanja square near buldana urban main branch Arya electrical Main road Buldana
Department of Kayachikitsa, 4th floor,APMs Ayurved Mahavidyalay Sion, near Sion railway station, Sion east mumbai 400022
Mumbai
MAHARASHTRA
443001
India |
| Phone |
7385845922 |
| Fax |
|
| Email |
ashwiniagrawal2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anaya Ashish Pathrikar |
| Designation |
Professor |
| Affiliation |
APMs, Ayurveda Mahavidyalay sion, Mumbai |
| Address |
Department of Kayachikitsa, APMs Ayurved Mahavidyalay, Near Sion Station, Sion East, Mumbai.
Department of Kayachikitsa,APMs Ayurved Mahavidyalay sion, near Sion railway station, Sion east mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ashwini Harish Agrawal |
| Designation |
PG scholar |
| Affiliation |
APMs Ayurveda Mahavidyalay sion, Mumbai |
| Address |
Karanja square near buldana urban main branch Arya electrical Main road Buldana
Department of Kayachikitsa,APMs Ayurved Mahavidyalay Sion, near Sion railway station, sion East, Mumbai
Mumbai
MAHARASHTRA
443001
India |
| Phone |
7385845922 |
| Fax |
|
| Email |
ashwiniagrawal2014@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwini Harish Agrawal |
APMs Seth R.V.Ayurvedic hospital |
Departmet of Kayachikitsa, Ayurvidya prasarak mandals ayurved mahavidyalay sion, near sion railway station sion east Mumbai 400022.
Mumbai
MAHARASHTRA |
7385845922
ashwiniagrawal2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalay IEC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrutadi kwath, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Eranda tail), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishor guggul, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All genders will be included
Age group 18 to 70 years
All patients clinically diagnosed as vatarakta
Hyperuricemic patients
Patient having uric acid level 6.5 to 12 mg per dl
|
|
| ExclusionCriteria |
| Details |
1) Patients with renal failure
2) Pregnant and lactating mother
3) patients with known case HIV and leprosy |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Sr. Uric acid |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sandhishula
Sandhigraha
Sandhitamravarnata
Sandhisparshasahatva
Sandhikriyakashtata
Sandhishotha
Daha |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Ayurveda is traditional system of Indian medicine which is being used for management of various disease and has found to be effective in modern era as well. Vatarakta is a disease where both vata and rakta are affected by distinct etiological factors. Pathology of disease originates in blood vessel and then get settled in joints. Initially it affects greater toe and then small joints and peripheral joints where it causes burning sensation, severe pain, stiffness, swelling and pigmentation. Out of many described medicine in texts, we choose Amrutadi kwath in comparison with kaishor guggul for the management of Vatarakta.
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